A new adjuvant improves the immune response to hepatitis B vaccine in hemodialysis patients

January 2, 2008

Original Article

Kidney International advance online publication 26 December 2007; doi:

10.1038/sj.ki.5002725

A new adjuvant improves the immune response to hepatitis B vaccine in

hemodialysis patients

N C T Kong1, J Beran2,3, S A Kee1, J L 4, C Sánchez4, J-M Bayas5, A

Vilella5, F Calbo-Torrecillas6, E López de Novales7, K Srinivasa8, M Stoffel9

and B Hoet10

1Nephroloyg/Dialysis Unit, Department of Medicine, National University Hospital

of Malaysia, Kuala Lumpur, Malaysia

2Vaccination and Travel Medicine Center, Poliklinka II, Hradec Kralove, Czech

Republic

3Department of Infectious Diseases, School of Medicine and University Hospital,

Hradec Kralove, Czech Republic

4Dialysis Unit, La Paz Hospital, Madrid, Spain

5Department of Preventive Medicine, Clinic Hospital, Barcelona, Spain

6Department of Preventive Medicine, Hospital Haya, Málaga, Spain

7Nephrology Department, Hospital Haya, Málaga, Spain

8Clinical Development Operations Center, GlaxoKline Biologicals, Bangalore,

India

9Clinical Regulatory & Labelling, GlaxoKline Biologicals, Rixensart,

Belgium

10Worldwide Clinical Development, GlaxoKline Biologicals, Rixensart,

Belgium

Correspondence: B Hoet, GlaxoKline Biologicals, 89 Rue de l'Institut, 1330

Rixensart, Belgium. E-mail: bernard.hoet@...

Received 28 February 2007; Revised 15 September 2007; Accepted 9 October 2007;

Published online 26 December 2007.

Abstract

Prehemodialysis and hemodialysis patients are at an increased risk of hepatitis

B infection and have an impaired immune response to hepatitis B vaccines. We

evaluated the immune response to the new adjuvant of hepatitis B vaccine AS04

(HBV-AS04) in this population. We measured antibody persistence for up to 42

months, and the anamnestic response and safety of booster doses in patients who

were no longer seroprotected. The primary vaccination study showed that HBV-AS04

elicited an earlier antibody response and higher antibody titers than four

double doses of standard hepatitis B vaccine. Seroprotection rates were

significantly higher in HBV-AS04 recipients throughout the study. The decline in

seroprotection over time was significantly less in the HBV-AS04 group with

significantly fewer primed patients requiring a booster dose over the follow-up

period. Solicited/unsolicited adverse events were rare following booster

administration. Fifty-seven patients experienced a serious adverse event during

the follow-up; none of which was vaccine related. When HBV-AS04 was used as the

priming immunogen, the need for a booster dose occurred at a longer time

compared to double doses of standard hepatitis B vaccine. Hence, in this

population, the HBV-AS04 was immunogenic, safe, and well-tolerated both as a

booster dose after HBV-AS04 or standard hepatitis B vaccine priming.

http://www.nature.com/ki/journal/vaop/ncurrent/abs/5002725a.html;jsessionid=0E99\

1B35159B6F1A951A31166F01142C

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January 2, 2008